Our Work Matters: We make products that save lives, ensuring better health and well-being for patients around the world. The Global Quality Systems & Compliance Lead is responsible for driving strategic initiatives that enhance global quality through innovation, compliance, and harmonization.
Requirements
Drive adoption of innovative technologies and digital solutions to improve quality processes.
Develop and maintain global SOPs and policies for quality.
Ensure compliance with international regulatory requirements (FDA, EMA, ISO, etc.).
Establish governance frameworks for data integrity across global operations.
Identify and implement process optimization opportunities.
Collect, standardize, and disseminate best practices across global sites.
Manage the Quarterly Management Review process across the organization
Develop Quality Management Maturity Models (QMM) for each quality system and track measurements, work with Systems to implement improvements
Develop and execute a comprehensive regulatory compliance strategy aligned with business objectives.
Issue and track regulation changes and how they impact each of the locations.
Create a culture and have discussions related to near misses during inspections/audits
Foster a culture of compliance and ethical business practices
Creation and management of inspection management tools
Create and manage Inspection Readiness program including scoring metrics
Develop and deliver training content for global quality and inspection management/compliance topics.
Facilitate knowledge-sharing forums and communities of practice.
Lead compliance training, programs for employees and management
